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Temozolomide With or Without Veliparib in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
Phase 2 trial testing Laboratory Biomarker Analysis in Recurrent Lung Small Cell Carcinoma in 97 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 97 |
| Start date | 27 July 2012 |
| Primary completion | 9 January 2017 |
| Estimated completion | 25 March 2026 |
| Sites | 14 locations across United States |
National Cancer Institute (NCI)
18 and older, any sex, with Recurrent Lung Small Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Compared across the two arms using a Fisher exact test.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Veliparib and Temozolomide) | 18 | |
| Arm II (Placebo and Temozolomide) | 11 |
Corresponding exact two-sided 95% confidence intervals will be calculated and reported in both arms of the study. Comparisons between treatment arms will be performed using Fisher-exact test.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Veliparib and Temozolomide) | 20 | |
| Arm II (Placebo and Temozolomide) | 6 |
Estimated in each treatment group using Kaplan-Meier method. Group comparisons will be performed using log-rank test.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Veliparib and Temozolomide) | 8.2 | 6.4 – 12.2 |
| Arm II (Placebo and Temozolomide) | 7 | 5.3 – 9.5 |
Tabulated According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. Summary level.
| Group | Value | 95% CI |
|---|---|---|
| Arm I (Veliparib and Temozolomide) | 52 | |
| Arm II (Placebo and Temozolomide) | 45 |
Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Arm I (Veliparib and Temoz… | Arm II (Placebo and Temozo… |
|---|---|---|---|
| Platelet count decreased | Investigations | — | — |
| Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Febrile Neutropenia | Investigations | — | — |
| Nervous system disorders - Other, specify | Nervous system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Anemia | Metabolism and nutrition disorders | — | — |
| Lung infection | Respiratory, thoracic and mediastinal disorders | — | — |
| Sepsis | General disorders | — | — |
| White blood cell decreased | Investigations | — | — |
| Acute Kidney Injury | Renal and urinary disorders | — | — |
| Anorexia | Gastrointestinal disorders | — | — |
| Dehydration | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Gastric perforation | Gastrointestinal disorders | — | — |
| Heart failure | Cardiac disorders | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pericardial effusion | Cardiac disorders | — | — |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Appendicitis perforated | Gastrointestinal disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Reaction | System | Arm I (Veliparib and Temoz… | Arm II (Placebo and Temozo… |
|---|---|---|---|
| Lymphocyte count decreased | Blood and lymphatic system disorders | — | — |
| Anemia | Blood and lymphatic system disorders | — | — |
| Platelet count decreased | Blood and lymphatic system disorders | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — |
| Fatigue | General disorders | — | — |
| White blood cell decreased | Blood and lymphatic system disorders | — | — |
| Alanine aminotransferase increased | Blood and lymphatic system disorders | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — |
| Alkaline phosphatase increased | Metabolism and nutrition disorders | — | — |
| Neutrophil count decreased | Blood and lymphatic system disorders | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — |
| Lipase increased | Metabolism and nutrition disorders | — | — |
| Febrile neutropenia | General disorders | — | — |
| Nervous system disorders - Other, specify | Nervous system disorders | — | — |
| Anorexia | General disorders | — | — |
| Aspartate aminotransferase increased | Blood and lymphatic system disorders | — | — |
| Nausea | General disorders | — | — |
| Creatinine increased | Metabolism and nutrition disorders | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — |
| Serum amylase increased | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: Platelet count decreased, Neoplasms ben/mal/unk (inc cyst/polyp) Other, spec, Febrile Neutropenia, Nervous system disorders - Other, specify, Abdominal pain, Dyspnea, Hyponatremia, Pleural effusion.
Data from ClinicalTrials.gov NCT01638546 adverse events section.
This randomized phase II trial studies how well temozolomide with or without veliparib works in treating patients with small cell lung cancer that has returned or does not respond to treatment. Temozolomide works by damaging molecules inside the cancer cells, such as deoxyribonucleic acid (DNA), that are needed for cancer survival and growth. Veliparib may stop the growth of tumor cells by blocking proteins that are needed for repairing the damaged DNA and it may also help temozolomide to kill more cancer cells. It is not yet know whether temozolomide is more effective with or without veliparib in treating patients with relapsed or refractory small cell lung cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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